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PODCAST

ASEAN MedTech Insights

Welcome to ASEAN MedTech Insights, the premier podcast dedicated to the thriving medical technology landscape of Southeast Asia. Each episode, we explore the cutting-edge innovations, investment trends, and regulatory developments in one of the world"s fastest-growing markets. Join us for exclusive interviews with the founders, executives, and visionaries shaping the future of healthcare in the ASEAN region.

science life sciences

All Episodes

02:57

Does Thailand's FDA Have a Secret AI Pathway? Pure...

ASEAN MedTech Insights ·

2025/09/13

This episode of ASEAN MedTech Insights dives into the regulatory landscape for AI-driven diagnostic tools in Thailand. As artificial intelligence transforms healthcare, many innovators wonder if specific, fast-tracked pathways exist for their technology in key ASEAN markets. We demystify the Thai FDA's position on this critical topic.We reveal that instead of a separate "AI pathway," Thailand employs a sophisticated, risk-based framework for Software as a Medical Device (SaMD). This episode

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03:36

Cracking the Code in Southeast Asia: Pure Global's...

ASEAN MedTech Insights ·

2025/09/12

The rise of AI in ASEAN's MedTech landscape is explosive, but the regulatory pathways are a complex and fragmented maze. This episode of ASEAN MedTech Insights dives deep into the current state of the ASEAN Medical Device Directive (AMDD) as it applies to AI-powered Software as a Medical Device (SaMD).We unpack the challenging reality behind the goal of harmonization, exploring how key countries like Singapore, Malaysia, and Thailand are independently interpreting the rules. This episode provides

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03:01

Malaysia's SaMD Maze: Your Expert Guide with Pure...

ASEAN MedTech Insights ·

2025/09/11

This episode of ASEAN MedTech Insights provides a deep dive into the regulatory landscape for Software as a Medical Device (SaMD) in Malaysia. We unravel the classification system used by the Malaysian Medical Device Authority (MDA), which aligns with the risk-based framework of the International Medical Device Regulators Forum (IMDRF).We explore how the classification, from low-risk Class A to high-risk Class D, is determined by two critical factors: the significance of the information provided

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03:30

Pure Global's Guide to Singapore's HSA AI Medical...

ASEAN MedTech Insights ·

2025/09/10

In this episode of ASEAN MedTech Insights, we demystify the regulatory landscape for AI-powered medical devices in Singapore. As a leading MedTech hub in ASEAN, Singapore's Health Sciences Authority (HSA) has established a robust framework that, while not specific to AI, presents unique challenges for innovators. We explore how the HSA applies its risk-based classification to AI devices and what this means for your market entry strategy.This session breaks down the critical "life cycle approach"

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03:30

Navigating ASEAN MedTech Regulations with Pure...

ASEAN MedTech Insights ·

2025/09/09

This episode of ASEAN MedTech Insights tackles the critical first step for market entry: correctly classifying your medical device under the ASEAN Medical Device Directive (AMDD). We demystify the risk-based system, focusing specifically on how to determine if your product falls into the low-risk Class A category. Understanding this classification is key to a streamlined and cost-effective registration process.We explore the specific rules that define Class A devices, from non-invasive products

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03:11

Navigating ASEAN's MedTech Maze: Are Low-Risk Device...

ASEAN MedTech Insights ·

2025/09/08

Navigating the complex regulatory landscape of Southeast Asia can be challenging, especially when it comes to low-risk medical devices. While the term "exemption" suggests an easy path to market, the reality across ASEAN is far more complex. This episode demystifies the rules for Class A devices in key markets like Singapore, Malaysia, and Thailand, revealing that a true exemption is the exception, not the rule. We explore how different national authorities interpret and implement the ASEAN Medical

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03:05

Unlocking ASEAN Markets: Pure Global's Expert Guide...

ASEAN MedTech Insights ·

2025/09/07

This episode of ASEAN MedTech Insights dives into the most efficient way to get your Class B medical device to market across Southeast Asia: the simplified registration pathway. We explore how leveraging an existing approval from a major global regulator, like the US FDA or with a CE Mark, can unlock expedited access to key ASEAN markets. We break down the specific requirements and processes for countries like Singapore and Malaysia, explaining how their "Abridged" and "Expedited" routes work in

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03:47

Philippine MedTech Entry Costs: Pure Global's Guide...

ASEAN MedTech Insights ·

2025/09/06

This episode of ASEAN MedTech Insights dives deep into the true cost of bringing a low-risk medical device to the Philippine market. We uncover the recent, dramatic changes in the Philippine FDA's fee structure that have caught many manufacturers off guard and explore the full spectrum of costs beyond the official government fees. We break down the strategic considerations for market entry, including the mandatory requirement of a Local Authorized Representative and the specifics of preparing a

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03:23

Pure Global's ASEAN MedTech Insights: Navigating...

ASEAN MedTech Insights ·

2025/09/05

Thinking of launching your Class A medical device in Indonesia? Many manufacturers assume that a low-risk classification means a simple, direct path to market. This common misconception can lead to costly delays and strategic dead-ends. This episode of ASEAN MedTech Insights breaks down the essential requirement for a local authorized representative for ALL device classes in Indonesia. We uncover why the Indonesian Ministry of Health mandates this, and explore the critical, long-term implications

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02:45

Pure Global's ASEAN MedTech Insights: Navigating...

ASEAN MedTech Insights ·

2025/09/04

This episode of ASEAN MedTech Insights demystifies the process of registering low-risk medical devices with the Thailand FDA. We clarify the critical difference between the 'Listing' pathway for Class 1 devices and the 'Notification' pathway for moderate-risk devices, providing a clear roadmap for manufacturers.We explore the detailed requirements, from the necessity of a local Thai license holder to the specifics of the ASEAN CSDT dossier format. Learn about the game-changing 'Positive List' and

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03:01

Pure Global's ASEAN MedTech Insights: Navigating...

ASEAN MedTech Insights ·

2025/09/03

Many MedTech manufacturers believe that low-risk, Class A medical devices are exempt from registration in Vietnam. This common misconception can lead to significant import delays, financial penalties, and blocked market access, demonstrating how a small misunderstanding of local regulations can derail an entire business strategy. This episode of ASEAN MedTech Insights dives deep into the realities of Vietnam's regulations under Decree 98/2021/ND-CP. We clarify that Class A devices are not exempt but

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02:58

Pure Global Presents: The Fastest Way to Register a...

ASEAN MedTech Insights ·

2025/09/02

This episode of ASEAN MedTech Insights demystifies the process of registering a Class I medical device in Malaysia. We break down why the "simplest" classification can often lead to unexpected delays and reveal the critical steps for a swift market entry. Learn about the crucial role of the Local Authorized Representative (LAR) and the MeDC@St system, and discover why meticulous preparation is the only true shortcut.We explore the common pitfalls that manufacturers face, from classification

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02:55

Navigating ASEAN's CSDT for Low-Risk Medical Devices:...

ASEAN MedTech Insights ·

2025/09/01

This episode of ASEAN MedTech Insights dives into a critical question for manufacturers of low-risk devices: Is the full ASEAN Common Submission Dossier Template (CSDT) actually required to enter the market? We uncover the reality behind the harmonized directive and reveal how key countries like Singapore, Malaysia, and Thailand have implemented their own unique, and often simplified, pathways. Imagine your company is ready to launch a new, innovative Class A device across Southeast Asia. You

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02:36

Navigating Singapore's HSA: A Pure Global Guide to...

ASEAN MedTech Insights ·

2025/08/31

This episode of ASEAN MedTech Insights demystifies the common misconception surrounding Class A medical device registration in Singapore. We uncover why being "exempt" from full registration doesn't mean a product is free from regulatory control, detailing the mandatory listing process with the Health Sciences Authority (HSA).We explore the essential steps, from appointing a local representative to compiling the necessary documentation and fulfilling post-market surveillance duties. For instance,

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03:00

Navigating MedTech in Malaysia: A Deep Dive into...

ASEAN MedTech Insights ·

2025/08/30

In this episode of ASEAN MedTech Insights, we explore the essential post-market surveillance and vigilance requirements for medical devices in Malaysia. We break down the key regulations under the Medical Device Act 2012 and explain the critical obligations for manufacturers and importers to ensure ongoing patient safety and market compliance. We delve into the practical steps companies must take, from maintaining meticulous distribution records to handling mandatory problem reporting. For example,

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02:57

ASEAN MedTech Insights by Pure Global: Navigating...

ASEAN MedTech Insights ·

2025/08/29

This episode of ASEAN MedTech Insights tackles a crucial question for global manufacturers: Are local clinical trials required to register your medical device in Southeast Asia? We move beyond the general guidelines of the ASEAN Medical Device Directive (AMDD) to uncover the complex and varied requirements of individual member states.We explore why your CE marking or FDA approval might not be enough, especially in key markets like Indonesia, Thailand, and Vietnam. Learn about the specific

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03:24

Unlocking the Philippine MedTech Market: A Pure...

ASEAN MedTech Insights ·

2025/08/28

This episode of ASEAN MedTech Insights provides a practical guide to the costs and timelines for medical device registration in the Philippines. We explore the critical role of device classification under the ASEAN Medical Device Directive and how it dictates your regulatory pathway, whether it's a simple notification for Class A devices or a full registration for Classes B, C, and D.We uncover the real-world timelines that often extend beyond official government estimates and break down the full

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03:31

MedTech ASEAN Insights by Pure Global: Mastering...

ASEAN MedTech Insights ·

2025/08/27

This episode of ASEAN MedTech Insights delves into the cornerstone of market access in Southeast Asia: the ASEAN Medical Device Directive (AMDD) risk classification system. We break down the four-tier framework—from low-risk Class A to high-risk Class D—that governs how devices are regulated across all 10 member states. Understanding this system is non-negotiable for any manufacturer looking to tap into this dynamic and growing market.We go beyond the basics to explore the critical nuances that

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02:43

Unlocking Vietnam's MedTech Market: A Pure Global...

ASEAN MedTech Insights ·

2025/08/26

This episode of ASEAN MedTech Insights tackles one of the most significant hurdles for medical technology companies entering Vietnam: the country's strict and specific labeling and language regulations. We demystify the requirements under key decrees like Decree 98/2021/ND-CP, providing a clear path to compliance for foreign manufacturers.We break down the practical solutions that successful companies use, focusing on the accepted practice of supplementary labeling. Learn what mandatory

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03:02

Pure Global's Guide to Indonesian Market Access:...

ASEAN MedTech Insights ·

2025/08/25

Navigating the Indonesian MedTech market presents a critical challenge for foreign manufacturers: the mandatory appointment of a Local Authorized Representative (LAR). This isn't merely an administrative step; it's a strategic decision that defines who controls your product's registration license and, ultimately, your access to one of Southeast Asia's largest markets. This episode of ASEAN MedTech Insights explores the two primary options for an LAR—appointing your distributor versus partnering

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